tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment (DCSErCPP)

Jean Schoenen

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pelvic Pain; Endometriosis; Transcranial Direct Current Stimulation; Spinal Cord Stimulation

Treatments: Device: Transcranial DCS Healthy Volunteers; Device: Transcranial DCS CPP patients; Device: Transspinal DCS Healthy Volunteers; Device: Transspinal DCS CPP patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02958423

B412201524615

Details and patient eligibility

About

The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain (CPP)

Full description

• 2 groups of 5 HV will receive tDCS or tsDCS (2mA, anodal, 20min) and the thermonociceptive threshold will be measured before and after the stimulation over the abdomen (hypogastric). The HAD scale and SF-36 will also be tested.

The treatment(s) that produces the greatest increase in pain thresholds will be chosen to treat 10 patients.

• 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment (tDCS or tsDCS) for 4 weeks (5 daily 20-min sessions per week), or, if no treatment modality was superior in HV, 5 patients will be treated by tDCS and 5 by tsDCS. Patients will fill in daily a dedicated diary 2 weeks before treatment, during the4-week treatment period and after this period as long as their pain level remains below 80% of their baseline pain intensity (VAS). Analgesic intake will also be monitored as well as HAD and SF-36 scores.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HV: good health.
• CPP patients: surgical diagnosis of endometriosis within the last 10 years; diagnosis of chronic pelvic pain (according to ACOG); mean VAS pain score >4 during severe episodes.

Exclusion criteria

• HV: chronic pain disorder; no regular medication or illicit drug use.
• CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 4 patient groups

Transcranial DCS Healthy Volunteers

Experimental group

Description:

5 HV will be treated once with transcranial direct current stimulation (2mA, anodal, 20 minutes) over right primary motor cortex with the Direct Current (DC) Stimulator (NeuroConn. Germany)

Treatment:

Device: Transcranial DCS Healthy Volunteers

Transspinal DCS Healthy Volunteers

Experimental group

Description:

5 HV will be treated once with transspinal direct current stimulation (2mA, anodal, 20 minutes) over the D10 spinal process with the Direct Current (DC) Stimulator (NeuroConn. Germany)

Treatment:

Device: Transspinal DCS Healthy Volunteers

Transcranial DCS CPP patients

Experimental group

Description:

5 chronic pelvic pain patients will be treated with transcranial direct current stimulation (2mA, anodal, 20 minutes) over right primary motor cortex 5 days/week for 4 weeks with the Direct Current (DC) Stimulator (NeuroConn. Germany)

Treatment:

Device: Transcranial DCS CPP patients

Transspinal DCS CPP patients

Experimental group

Description:

5 chronic pelvic pain patients will be treated with transspinal direct current stimulation (2mA, anodal, 20 minutes) over the D10 spinal process 5 days/week for 4 weeks with the Direct Current (DC) Stimulator (NeuroConn. Germany)

Treatment:

Device: Transspinal DCS CPP patients